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Clinical Trials

Turning Point Therapeutics is a clinical-stage biopharmaceutical company currently enrolling eligible patients in TRIDENT-1, a study of repotrectinib in patients with certain solid tumor cancers.

TRIDENT-1

A Study of Repotrectinib (TPX-0005) in Patients with Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Rearrangements

TRIDENT-1 is enrolling patients in a Phase 1/2 multi-center trial evaluating our lead drug candidate, repotrectinib, for the treatment of patients with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as patients with ROS1+, NTRK+ or ALK+ advanced solid tumors. Repotrectinib is being assessed for safety, tolerability, pharmacokinetics and antitumor activity.

Tumors with ROS1, NTRK and ALK gene mutations or rearrangements have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing treatments from targeting and treating the tumor as effectively. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies, and may circumvent some the resistance mechanisms found in tumors with ROS1, NTRK and ALK mutations.

A Precision Oncology Approach

The TRIDENT-1 study will be using next-generation sequencing to determine whether tumor cells carry the genetic mutations of interest: ROS1, NTRK, ALK. These genetic tests help identify patients with tumors that are most likely to respond to treatment.

Where are the trials located?

TRIDENT-1 study locations are currently open at medical centers in the U.S. and South Korea, with additional locations being added soon. You may contact the site nearest you, or for more information, contact us at clinical@tptherapeutics.com, or visit the TRIDENT-1 page at www.ClinicalTrials.gov.

How can I learn more?

Visit www.ClinicalTrials.gov
If you have questions about our clinical trials, you can contact us via email at clinical@tptherapeutics.com or by phone at 858-276-0005.

Compassionate Use

Compassionate use, also called “expanded access,” provides a pathway for patients with serious diseases to gain access to drugs that are being tested, but have not yet been approved by the U.S. Food and Drug Administration. These drugs are normally available only to people who are taking part in a clinical trial. Being able to use one of these drugs when you are not in a clinical trial is referred to as compassionate drug use.

Access to investigational treatments requires not only FDA’s review and authorization but also the active involvement and cooperation of other parties, including health care providers and the drug company.

In addition to Compassionate Use, the Right to Try Act of 2017 provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase I clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

At Turning Point Therapeutics, we support the need for compassionate use programs. Our goal is to provide study drug access at the appropriate time and in the correct context for patients with life-threatening diseases. We will review compassionate use requests on a case-by-case basis, considering factors including:

  • Whether the patient is eligible for any current clinical trial that’s using the drug
  • Whether comparable treatment options exist 
  • Whether compassionate use is likely to have benefits that outweigh the risks 
  • Whether granting patients use of a drug would interfere with ongoing clinical trials

For more information, please contact us at compassionate@tptherapeutics.com.

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